- Catalent Pharma Solutions (Harmans, MD)
- **Job Title:** Supervisor, Manufacturing Batch Record Review **Location:** Harmans, Maryland **Company:** Catalent Inc. **About Us:** Catalent, Inc. is a ... vector-based therapies and vaccines. **Position Overview:** The Supervisor, Manufacturing Batch Record Review is responsible...the review and successful release of all batch records used in Catalent manufacturing, coordinating… more
- Novo Nordisk (Durham, NC)
- …what matters. The Position Perform quality review & approval of Batch Production Records (BPRs), Change Requests (CR's), Deviations & other documentation ... & approve documentation for Quality approval - components/raw material, batch records , change control requests, deviations &...& how to apply required + Understanding of the Batch Review Processes required + Understanding of… more
- ThermoFisher Scientific (Greenville, NC)
- …ensuring strict adherence to Good Manufacturing Practice (GMP) standards. + Evaluate batch record documentation and collaborate with Production and Quality ... liabilities and preserving client happiness. + Conduct detailed analysis on batch record data, tracking errors and improving process flow for efficiency and… more
- Boehringer Ingelheim (Columbus, OH)
- …of 2-3 days per week on-site.** **Duties & Responsibilities** + Independently performs batch record review and/or final disposition of drug products ... reflect Boehringer Ingelheim's high regard for our employees. The Specialist III, Batch Disposition is responsible for ensuring that batches manufactured by Contract… more
- Catalent Pharma Solutions (Harmans, MD)
- …records , product labels, SMPs, and product specific documents. + Independently executes batch record review for completeness, accuracy and cGMP ... and engineering execution in accordance with good documentation practices (GDP), including but not limited to: executed batch records , master batch … more
- ThermoFisher Scientific (Greenville, NC)
- …Join our team at Thermo Fisher Scientific to contribute to vital projects, such as curing cancer, safeguarding the environment, and ensuring food safety. ... **Location/Division Specific Information** This position is located at our Greenville, NC site. We have industry-leading sterile injectable facilities providing solutions to take crucial products from Pre-Clinical to the market. Pharmaceutical products come in… more
- Catalent Pharma Solutions (Philadelphia, PA)
- …years of experience in QADC is strongly preferred + Experience working with packaging batch records review and approval, release of products, packaging, ... batch record documentation, reviewing and approving batch records , and releasing batch ...The position requires the individual to prepare customer files, review and approve batch records ,… more
- Mallinckrodt Pharmaceuticals (Raleigh, NC)
- …Daily Notification to Management. They provide support for customer inquiries, gap assessments, batch record review , and label preparation as assigned. ... including but not limited to the following: Annual Product Review , Management Review , Audits, Product Complaints, CAPA,... records to including but not limited to, batch record scanning, documentation error tracking and… more
- Lilly (Indianapolis, IN)
- …owner promptly. Escalate any critical issues to the QA Management in a timely manner. + Review related batch records (inclusive of third-party batch ... such as deviations, non-conformance investigations, change controls, procedures, master batch record reviews, technical protocols/reports, validations, batch… more
- Catalent Pharma Solutions (Harmans, MD)
- …as routine production tasks. + Proficient knowledge of documentation including comprehension, review & establishing Batch Production Records , SOP's, ... manufacturing and support area of manufacturing using SOP's and batch records . Operating production equipment for upstream...Ensure batches adhere to established Quality standards. + GMP batch review and close-out with Quality Assurance… more
- PCI Pharma Services (Rockford, IL)
- …to ensure compliance standards are met and maintained. Facilitates customer questions for Batch Record review and Documentation Updates. Maintains a positive ... organizing internal and customer approval of batch records and specifications. 3. Assist with performing record...information. 6. Assist in the preparation of annual product review data. 7. Assist with generating and presenting quality… more
- Novo Nordisk (Bloomington, IN)
- …group has oversight of the manufacturing areas, including process technology transfer, master batch record review and approval, on-the-floor support, product ... of GMP documentation such as Standard Operating Procedures, Master Batch Record review and SMPs...+ Supports issuance of controlled documents for production, including Batch Production Records , Product Labels, and forms… more
- Novo Nordisk (Bloomington, IN)
- …+ Assist with revision of GMP documentation such as Standard Operating Procedures, Master Batch Record review and SMPs + Initiate deviations as required ... Perform audits of manufacturing and support areas, including in-process batch record review for adherence...and approval of project related documents such as Master Batch Production Records , technical transfer, and process… more
- PCI Pharma Services (Philadelphia, PA)
- …in-process inspections have been performed within compliance. The Quality Auditor performs real-time batch record review during batch processing in ... process equipment are within required specifications. + Performs in-line review of batch record (MPI)...within acceptable job parameters. + Proactively identify gaps in batch records to mitigate deviations and documentation… more
- Nitto Denko Corp. (Milford, MA)
- …the manufacturing process and operations. This includes leading and managing multiple QA teams for batch record review , batch disposition, and on the ... guidance to the QA team supporting GMP manufacturing activities, batch record review , and ...approve GMP documents, including deviation, change control, CAPA reports, batch records , SOPs, and material specifications, and… more
- PCI Pharma Services (San Diego, CA)
- …Objective:** The Quality Assurance Coordinator is primarily responsible for performing executed batch record review , ensuring the documentation is accurate, ... and customer service. **Essential Duties and Responsibilities:** + Perform documentation and records review of completed orders to ensure compliance with CGMP's… more
- Fujifilm (Holly Springs, NC)
- …role, you will oversee our Quality Product and Validation teams, along with the batch review and release teams. Your responsibilities will include ensuring that ... and manages the QA DSM Operations teams, including the Batch Review and Release teams and the...other GMP functions (manufacturing, MSAT, Engineering) * Strong track record of driving operational excellence * Experience with the… more
- Pfizer (Sanford, NC)
- …but are not limited to, Aseptic Observations, Acceptable Quality Limit (AQL) testing, batch record review , line clearance approvals, alarms evaluation, on ... the floor triage, and on the floor real time batch record review . The Senior...the manufacturing floor including support for activities such as review of in-process records , AQL, aseptic observations,… more
- BeiGene (Hopewell, NJ)
- …+ Supervises direct reports within the Manufacturing QA and Compliance Team, assists with batch review and release as necessary. QA, Mfg. shop floor QA ... activities with resources as needed. + Support all QA shop floor and batch systems to ensure compliance with FDA/EU regulations, covering cGMP for commercial… more
- Abeona (Cleveland, OH)
- …of the quality systems in support of a cGMP Operation for production processes relating to batch record review and release from start to end of manufacturing ... and conducting performance reviews in a timely and objective manner. + Review batch -related documentation and ensure resolution of issues to release… more